MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 12FR 43IN W STYL YPOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721252E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the purple cap/end of the guidewire/stylet came off when removing it from the tube.They flushed with 10ml of water prior to removing the stylet.No injuries were reported.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.A gemba walk was performed, and the manufacturing process was reviewed.All process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging, and inspections performed to the product.In addition, qc inspections are performed to the product for material release; and production personnel performs a 100% visual inspection during the packaging process, in order to detect and discard any identified product issues.A sample was not received for evaluation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 12FR 43IN W STYL YPOR
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15545029
• Report Number: 9612030-2022-03419
• Device Sequence Number: 6575262
• Product Code: KNT
• UDI-Device Identifier: 10884521583030
• UDI-Public: 10884521583030
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884721252E
• Device Catalogue Number: 8884721252E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown